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Completed

NCT Number: NCT02956057

Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy

Study evaluates the efficacy and tolerability of low volume preparations compared with conventional 4L polyethylene glycol prior to colonoscopy

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Key information

Conditions

Colonoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty Hospital Kralovske Vinohrady

Prague, 10024, Czechia

About this study

To compare the efficacy and tolerance of standard polyethylene glycol to low volume sodium picosulphate/magnesium citrate and polyethylene glycol/ascorbic acid in a single or split dose regimen for colonoscopy bowel preparation in a head-to-head design.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects referred to diagnostic or therapeutic colonoscopy

Exclusion criteria

  • ileus
  • known or suspected bowel obstruction
  • active bowel inflammation
  • pregnancy
  • any presence of serious medical conditions
  • history of prior colonic or rectal surgery
  • inability to obtain valid data from subject

Treatment and study plan

Polyethylene Glycols

Drug

Natrium picosulfate / Magnesium citrate

Drug

Polyethylene glycol / Ascorbic acid

Drug

Primary outcomes

  1. Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2)

    Time frame: One day

    Bowel preparation score 1+2 expressed on Aronchick scale (1 the best, 5 the worst)

Secondary outcomes

  1. Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2)

    Time frame: One day

    Tolerance of Bowel Preparation Assessed by VAS score 1+2 ( 1-excellent, 5-very poor)

Sponsors and collaborators

Lead sponsor

Tomas Bata Hospital, Czech Republic

Other

Collaborators

  • Brno University Hospital
  • Faculty Hospital Kralovske Vinohrady

Registry information

Official study title

A Head-to-head Comparison of Efficiency and Tolerance of 4-L Polyethylene Glycol and Sodium Picosulphate/ Magnesium Citrate, Polyethylene Glycol/Ascorbate Before Colonoscopy

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 4, 2016
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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